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Recall Observatory FDA recall evidence

Drug product

Tadalafil 20 mg Troche

D-0818-2020

December 18, 2019

Class II

Product summary

Firm
MPRX, Inc. dba Medical Park Pharmacy
Event
Event 84527
Status
Terminated
Classification
Class II
Quantity
9 bottles
Official record key
drug-enforcement:D-0818-2020

Official wording

Reason: Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.

Code information: Lots: 61137:42 Use by: 03/08/2020; 61324:99 Use by: 04/04/2020; 60856:42 Use by: 02/02/2020

Distribution pattern: TX

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Incorrect or missing